Pharmacy Prior Authorization Criteria

Administrative Non-Formulary & Excluded Drug Exceptions Process

Indications for Prior Authorization

Criteria

A non-formulary or excluded* contraceptive drug

*Please consult client-specific resources to confirm whether benefit exclusions should be reviewed for medical necessity. **Examples of non-contraception uses: (1) Abnormal or excessive bleeding disorders (eg, amenorrhea, oligomenorrhea, menorrhagia, dysfunctional uterine bleeding); (2) Acne; (3) Decrease in bone mineral density; (4) Dysmennorrhea; (5) Endometriosis; (6) Hirsutism; (7) Irregular menses / cycles; (8) Ovarian cysts; (9) Perimenopausal symptoms; (10) History of Pelvic Inflammatory Disease (PID); (11) Polycystic Ovarian Syndrome (PCO or PCOS); (12) Premenstrual Syndrome (PMS); (13) Premenstrual Dysphoric Disorder (PMDD); (14) Prevention of endometrial and/or ovarian cancer; (15) Prevention of menstrual migraines; (16) Turner’s syndrome; (17) Uterine fibroids or adenomyosis. ***Any justification of medical necessity/appropriateness provided by the prescriber is adequate to approve access.

Administrative

Length of Approval: 12 Month(s)

• One of the following:
• Both of the following:
• Patient is using the requested product for contraception or other FDA-approved condition**
• The requested product is medically necessary***
OR
• If requested for an off-label indication, the off-label guideline approval criteria have been met

A non-formulary or excluded* drug

*Please consult client-specific resources to confirm whether benefit exclusions should be reviewed for medical necessity. *If the target drug is listed on the ORx Commercial grid, the patient must try and fail, or have specific medical reason(s) for why the number of alternatives specified by the grid is not appropriate. ^OTC equivalent refers to any covered or non-covered OTC equivalent product. If the diagnosis provided for the target drug is FDA approved/compendia supported, then consider the OTC equivalent(s) to have the same FDA approval/compendia support.

Administrative

Length of Approval: 6 Month(s)

• Both of the following:
• One of the following:
• If the requested drug has a formulary alternative with the same active ingredient, both of the following:
• Submission of medical records (e.g., chart notes) documenting the patient has experienced intolerance (e.g., allergy to excipient) with a formulary alternative that has the same active ingredient
AND
• Submission of medical records (e.g., chart notes) or paid claims documenting the patient has tried and failed at least 2 additional formulary alternatives within the same therapeutic class. If only 1 formulary alternative within the therapeutic class is available, the patient must have tried the formulary alternative within the therapeutic class AND 1 additional formulary alternative. If there are no formulary alternatives within the same therapeutic class, the patient must have failed 2 formulary alternatives or have a contraindication or intolerance to all formulary alternatives.
OR
• If the requested drug is a fixed-dose combination product with each individual ingredients available on formulary, both of the following:
• Submission of medical records (e.g., chart notes) documenting the patient has experienced intolerance (e.g., allergy to excipient) with the individual ingredients in the combination product
AND
• Submission of medical records (e.g., chart notes) or paid claims documenting the patient has tried and failed at least 2 additional formulary alternatives
OR
• If only over-the-counter (OTC) equivalents^ are available, patient has tried and failed or has contraindications or intolerance to 3 OTC equivalents. If only 1 or only 2 equivalents are available, the patient must have failed or has contraindications or intolerance to all available OTC equivalents [document drug(s), dose, duration of trial]
OR
• If formulary alternatives are available and do not meet above scenarios, submission of medical records (e.g., chart notes) or paid claims documenting patient has tried and failed at least 3 formulary alternatives or has contraindications or intolerance to all formulary alternatives. If only 1 or only 2 alternatives are available, the patient must have failed or has contraindications or intolerance to all available formulary alternatives.
OR
• No formulary alternative or OTC equivalent is available to treat the patient's condition
AND
• One of the following:
• Both of the following:
• Requested drug is FDA-approved for the condition being treated
AND
• Additional requirements listed in the "Indications and Usage" sections of the prescribing information (or package insert) have been met (e.g., first line therapies have been tried and failed, any testing requirements have been met, etc.)
OR
• If requested for an off-label indication, the off-label guideline approval criteria have been met

P & T Revisions

2024-10-24, 2024-07-25, 2024-04-02, 2024-03-06, 2023-12-22, 2023-11-27, 2023-11-01, 2023-09-15, 2022-11-02, 2022-08-23, 2022-07-22, 2022-07-18, 2022-01-11, 2021-11-03, 2021-09-28, 2021-05-26, 2021-05-21, 2021-05-05, 2021-03-01, 2021-01-04, 2020-12-31, 2020-11-16, 2020-02-25, 2019-11-01

References

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Revision History

• 2024-10-24: Annual review, no changes.
• 2024-07-25: Update criteria to clarify intent. Add operational note to clarify OTC requirement.
• 2024-04-02: Updated operational note for non-formulary or excluded drug. No changes to clinical criteria.
• 2024-03-06: Criteria update.
• 2023-12-22: No changes to intent. Added operational note for non-formulary or excluded drug criteria. Removed Non-Preferred Non-Formulary or Excluded Medication criteria and move to its own stand alone guideline.
• 2023-11-27: Updated Non-Formulary or Excluded drug criteria to reorder criteria. No changes to clinical intent. Removed Auvi-Q as target drug.
• 2023-11-01: Annual review: No updates required.
• 2023-09-15: Updated program. Added criteria for Non-Preferred Non-Formulary or Excluded drugs to this guideline to consolidate.
• 2022-11-02: Annual review: No updates required.
• 2022-08-23: Update background
• 2022-07-22: Create contraceptive specific criteria that allows for approval upon medical necessity.
• 2022-07-18: Update Guideline.
• 2022-01-11: Annual review: No updates required.
• 2021-11-03: Annual review: No updates required.
• 2021-09-28: Renamed guideline to 'Administrative Non-Formulary & Excluded Drug Exceptions Process' to differentiate from drug-specific non-formulary/excluded guidelines.
• 2021-05-26: Renamed guideline to 'Administrative Non-Formulary & Excluded Drug Exceptions Process' to differentiate from drug-specific non-formulary/excluded guidelines.
• 2021-05-21: Addition of EHB formulary to guideline, no changes to criteria
• 2021-05-05: Removed Non-Form Non-Preferred criteria from NF admin guideline per PA team request.
• 2021-03-01: Removed Aplenzin as target, moved to Non-Formulary Drugs of Clinical Concern
• 2021-01-04: Updated Formulary alternatives table
• 2020-12-31: Added targets to Non-Form Non-Preferred criteria for 1.1.21 eff date and updated alternative table in background section.
• 2020-11-16: Attached Non-Form Non-Preferred criteria to NF admin guideline per PA team request to facilitate proper NF reviews.
• 2020-02-25: Added keywords "non", "non-form", and "non-formulary" to criteria section per PA request.
• 2019-11-01: Updated to add criteria for when there are only OTC equivalents.

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